Ileal Pouch-Anal Anastomosis Registry

NCT ID: NCT01026480

Last Updated: 2017-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

936 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2017-03-16

Brief Summary

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Little is known about the factors that predispose patients to complications after an ileal pouch-anal anastomosis procedure (IPAA). Our goal is to establish a registry that prospectively captures pre- and post-surgical data from participants. Retrospective studies concerning IPAA outcomes and will be conducted using these data.

Detailed Description

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In order to better understand the long-term outcomes following IPAA, a registry that collects pertinent information about the underlying disease and its treatments and complications in an organized manner must be established. Establishing this Registry will allow us to follow patients who have an IPAA and organize retrospective medical information into a meaningful system.

Conditions

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Ileal Pouch-Anal Anastomosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IPAA Patients

Patients who have had their IPAA procedures performed by Dr. Becker

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with one of the following: Ulcerative colitis, Crohn's disease, Indeterminate colitis, Familial adenomatous polyposis, Hereditary nonpolyposis colorectal cancer, Lynch syndrome I or II, or Gardners' syndrome
* Treated by a Center for Digestive Disorders physician
* Scheduled for, or has undergone, ileal pouch-anal anastomosis procedure

Exclusion Criteria

* Patients who do not speak a language for which the IRB has approved an Informed Consent Form or Short Form
* Patients who are currently incarcerated
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Francis Farraye, MD

Faculty member

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James M Becker, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Francis A Farraye, MD

Role: STUDY_DIRECTOR

Boston Medical Center

Arthur F Stucchi, PhD

Role: STUDY_DIRECTOR

Boston University

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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http://www.bmc.org/ipaa/registry.htm

IPAA Registry at Boston Medical Center

Other Identifiers

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H-28518

Identifier Type: -

Identifier Source: org_study_id

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